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Recruiting Phase 3 NCT06855498

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Phase 3 – large-scale trial before approval
Conditions: Hidradenitis Suppurativa (HS)

Sponsor: Incyte Corporation

trial.available_in: БГ
Overview
Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.
Who can participate
Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment. * Received clinical benefit from treatment with study drug during the parent study, as determined by the investigator. * Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements. * Willingness to avoid pregnancy or fathering children as defined in the protocol. * Willingness and ability to comply with the study Protocol and procedures. Exclusion Criteria: * Had been permanently discontinued from study treatment during the parent study. * Had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study. * Received at least 1 dose of either of the following therapies within the 28 days prior to starting treatment in this rollover study: * Biologic immunomodulator (examples include but are not limited to adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab). * Live, attenuated vaccine. * Plans for administration of a live, attenuated vaccine during this study or within 8 weeks after the last dose of study drug. * Women who are pregnant (or who are considering pregnancy) or breastfeeding. * Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class. * Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. * Any condition that would, in the investigator's and/or sponsor's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Locations 19
Argentina (1)
Investigative Site AR005
Buenos Aires
NOT_YET_RECRUITING
Australia (1)
Investigative Site AU001
Charleston , New South Wales
Belgium (1)
Investigative Site BE007
Bruges
NOT_YET_RECRUITING
Bulgaria (1)
Investigative Site BG008
Dupnitsa
NOT_YET_RECRUITING
Canada (1)
Investigative Site CA023
Calgary , Alberta
NOT_YET_RECRUITING
Chile (1)
Investigative Site CL002
LAS Condes Santiago
NOT_YET_RECRUITING
Czech Republic (1)
Investigative Site CZ002
Ostrava-poruba
NOT_YET_RECRUITING
Denmark (1)
Investigative Site DK002
Roskilde
NOT_YET_RECRUITING
France (1)
Investigative Site FR014
Antony
Greece (1)
Investigative Site GR001
Athens
Hungary (1)
Investigative Site HU001
Debrecen
NOT_YET_RECRUITING
Italy (1)
Investigative Site IT012
Bari
NOT_YET_RECRUITING
Netherlands (1)
Investigative Site NL005
Amsterdam
NOT_YET_RECRUITING
Poland (1)
Investigative Site PL013
Cracov
NOT_YET_RECRUITING
South Korea (1)
Investigative Site KR006
Ansan-si
Spain (1)
Investigative Site ES025
Alicante
NOT_YET_RECRUITING
Switzerland (1)
Investigative Site CH003
Bern
NOT_YET_RECRUITING
United Kingdom (1)
Investigative Site GB003
Birmingham
NOT_YET_RECRUITING
United States (1)
Investigative Site US086
Birmingham , Alabama
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
28.02.2025
Completion date
28.02.2028
Registry ID
NCT06855498
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.